Skip to content
Recall Observatory FDA recall evidence

Drug product

Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York

D-0696-2021

July 15, 2021

Class II

Product summary

Firm
API Solutions Inc.
Event
Event 88289
Status
Terminated
Classification
Class II
Quantity
1 bottle
Official record key
drug-enforcement:D-0696-2021

Official wording

Reason: cGMP Deviations

Code information: Lot #: AZA181105, Exp 11/09/2021

Distribution pattern: AL, AZ, CO, FL, VA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations